In this insightful webinar, Kevin Breesch of Nelson Labs will address the significant challenges associated with toxicological-safety assessments for parenteral packaging systems. Parenteral packaging systems are critical for the safe delivery of medications, but they pose unique toxicological challenges, particularly concerning extractables and leachables (E&L). Kevin will explore typical toxicological issues, such as evaluating daily exposure to various compounds based on appropriately selected thresholds.
Key topics covered will include:
- Difficulties in Daily Exposure Evaluations: Assessing daily exposure levels for a range of compounds is crucial for ensuring patient safety. Kevin will discuss the methodologies used to determine these exposure levels and the challenges encountered in setting appropriate thresholds.
- Hazard and Risk Evaluation: The webinar will delve into the typical burdens of hazard and risk evaluation, particularly for data-poor substances often found in rubber closure systems. Kevin will provide insights into how to navigate these challenges and ensure comprehensive safety assessments.
- E&L Examples and Critical Toxicological Endpoints: Through selected E&L examples, the webinar will illustrate the critical toxicological endpoints that need to be considered. Various methods for evaluating these endpoints will be discussed, with a focus on deriving appropriate safety limits.
Key Learning Objectives:
- Selecting the Right Threshold for E&L Screening Methodologies: Understanding how to choose the correct thresholds is vital for effective E&L screening. This segment will provide practical guidance on threshold selection.
- Determining Reasonable Exposure Levels: Learn how to accurately determine the reasonable exposure of compounds to patients, ensuring their safety.
- Overcoming Toxicological-Safety Hurdles: Gain insights into the common toxicological-safety hurdles and strategies to overcome them, ensuring robust and reliable safety assessments.
This webinar aims to equip attendees with the knowledge and tools needed to address the complex challenges of toxicological-safety assessments in parenteral packaging systems. By understanding these key aspects, participants will be better prepared to ensure the safety and efficacy of their products, ultimately protecting patient health.